Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT04067934
Eligibility Criteria:
Inclusion Criteria:
* confirmed diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) at least 6 months prior to study involvement
* aged 10 to 17.9 years (inclusive)
* ability to provide written informed consent, or assent with accompanying parent/guardian consent
* ability to mobilise and perform exercise independently
* disease in remission, or mildly/moderately active, according to weighted Paediatric Crohn's disease activity index (wPCDAI) or Paediatric ulcerative colitis activity index (PUCAI)
* stable medication for \>4 weeks prior to study, and no planned changes of medication during study period
Exclusion Criteria:
* lack of capacity to provide consent or assent
* pregnancy (females)
* recent (\<12 weeks) surgery, or planned surgery during intervention period
* significant contraindication to high-impact exercise
* significant comorbidity
* use of medication known to affect bone turnover (excluding that used to treat IBD \[i.e. glucocorticoids\])
* BMI \> +3.5 standard deviation score (SDS)
* participating in \>2 hours per week structured exercise (excluding school physical education)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT04067934
Study Brief:
Protocol Section:
NCT04067934